TY - JOUR
AU1 - Cunningham, Coleen K
AU2 - Karron, Ruth A
AU3 - Muresan, Petronella
AU4 - Kelly, Matthew S
AU5 - McFarland, Elizabeth J
AU6 - Perlowski, Charlotte
AU7 - Libous, Jennifer
AU8 - Oliva, Jennifer
AU9 - Jean-Philippe, Patrick
AU1 - Moye, Jack
AU1 - Schappell, Elizabeth
AU1 - Barr, Emily
AU1 - Rexroad, Vivian
AU1 - Johnston, Benjamin
AU1 - Chadwick, Ellen G
AU1 - Cielo, Mikhaela
AU1 - Paul, Mary
AU1 - Deville, Jaime G
AU1 - Aziz, Mariam
AU2 - Yang, Lijuan
AU2 - Luongo, Cindy
AU2 - Collins, Peter L
AU2 - Buchholz, Ursula J
AU2 - ,
AB - BackgroundThis United States-based study compared 2 candidate vaccines: RSV/ΔNS2/Δ1313/I1314L, attenuated by NS2 gene-deletion and temperature-sensitivity mutation in the polymerase gene; and RSV/276, attenuated by M2-2 deletion.MethodsRSV-seronegative children aged 6–24 months received RSV/ΔNS2/Δ1313/I1314L (106 plaque-forming units [PFU]), RSV/276 (105 PFU), or placebo intranasally. Participants were monitored for vaccine shedding, reactogenicity, and RSV serum antibodies, and followed over the subsequent RSV season.ResultsEnrollment occurred September 2017 to October 2019. During 28 days postinoculation, upper respiratory illness and/or fever occurred in 64% of RSV/ΔNS2/Δ1313/I1314L, 84% of RSV/276, and 58% of placebo recipients. Symptoms were generally mild. Cough was more common in RSV/276 recipients than RSV/ΔNS2/Δ1313/I1314L (48% vs 12%; P = .012) or placebo recipients (17%; P = .084). There were no lower respiratory illness or serious adverse events. Eighty-eight and 96% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 recipients were infected with vaccine (shed vaccine and/or had ≥4-fold rises in RSV antibodies). Serum RSV-neutralizing titers and anti-RSV F IgG titers increased ≥4-fold in 60% and 92% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 vaccinees, respectively. Exposure to community RSV during the subsequent winter was associated with strong anamnestic RSV-antibody responses.ConclusionsBoth vaccines had excellent infectivity and were well tolerated. RSV/276 induced an excess of mild cough. Both vaccines were immunogenic and primed for strong anamnestic responses.Clinical Trials RegistrationNCT03227029 and NCT03422237.
TI - Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/ΔNS2/Δ1313/I1314L and RSV/276 in RSV-Seronegative Children
JF - Journal of Infectious Diseases
DO - 10.1093/infdis/jiac253
DA - 2022-06-23
UR - https://www.deepdyve.com/lp/oxford-university-press/evaluation-of-recombinant-live-attenuated-respiratory-syncytial-virus-DGDKBKVxHg
SP - 2069
EP - 2078
VL - 226
IS - 12
DP - DeepDyve
ER -